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BOSTON--(BUSINESS WIRE)--Patients with chronic hepatitis C who respond quickly to PEGASYS« (peginterferon alfa-2a) and COPEGUS« (ribavirin, USP) may have an excellent chance of achieving treatment success with a shortened course of therapy, according to interim results presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Three-quarters of patients with the difficult-to-treat viral genotypes 1 and 4 who had a rapid viral response (RVR) - defined as undetectable levels of the virus after four weeks of therapy - achieved treatment success after 24 weeks of therapy. (Patients with these genotypes are typically treated for 48 weeks.)

"These results show that within a month of starting therapy with peginterferon alfa-2a and ribavirin, we can give excellent news to some patients with difficult-to-treat genotypes - that they are likely to achieve treatment success with six months of therapy rather than 11 months," said Donald Jensen, M.D., Professor of Medicine and Director of the Center for Liver Diseases at the University of Chicago Hospital in Chicago. "If confirmed in further study, these data are encouraging because they could help motivate more patients to seek treatment and to stay on treatment."

Currently, the best indicator of treatment success is a sustained viral response (SVR), defined by undetectable hepatitis C virus RNA in the blood six months after the end of treatment. Long-term studies show that the virus returns to detectable levels in very few patients who achieve an SVR.

In this study, patients received PEGASYS 180mcg/week once weekly plus a 1000-1200mg daily dose of COPEGUS. After four weeks of treatment, virus levels in the blood were measured to identify patients who achieved an RVR. This group of patients was treated for another 20 weeks, receiving a total of 24 weeks of therapy (n=104). All other patients continued on treatment and were reassessed at week 12. Those who had an early virological response (EVR, defined as undetectable viral load or a drop in viral load to less than one percent of pre-treatment viral load) were randomized to receive either 48 weeks (n=105) or 72 weeks (n=108) of therapy. Those who did not have an EVR continued treatment up to 72 weeks (n=56). The study was designed to allow a comparison of 48 vs. 72 weeks of therapy in patients who achieved an EVR. Results of the study showed:

78 percent of patients who achieved an RVR in the study achieved an SVR with 24 total weeks of therapy;among those who did not achieve an RVR but had an EVR, SVR rates were similar for 48 or 72 weeks of treatment (57 percent and 59 percent of patients, respectively);patients who did not have an EVR were highly unlikely to achieve an SVR (four percent) even after 72 weeks of treatment. Higher Fixed Dosing with PEGASYS in Difficult-to-Treat Patients

The results of another study presented at AASLD show that intensifying treatment with a higher fixed dose of PEGASYS along with a higher dose of COPEGUS may yield higher response rates in patients with several characteristics that make hepatitis C more difficult-to-treat. It is well recognized that response rates to treatment can be significantly lower in patients who have these specific characteristics together, such as infection with genotype 1, high levels of virus in the blood and heavy bodyweight.

"We have known for some time that certain patients have characteristics that make their disease more difficult to treat, and improving their treatment success rates with currently available medications is an urgent need," said Michael W. Fried, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill. "If strategies using intensified treatment with peginterferon alfa-2a and ribavirin are validated in larger studies, these findings suggest that even more patients living with chronic hepatitis C can have treatment success."

This randomized, double-blind study enrolled 188 adults with previously untreated genotype 1 chronic hepatitis C infection, a bodyweight of more than 85 kg and high blood levels of hepatitis C (HCV RNA level greater than 800,000 IU/mL). Patients received 48 weeks of treatment with PEGASYS at either the standard fixed dose of 180mcg/week or a higher fixed dose of 270mcg/week, plus COPEGUS (ribavirin) at the standard dose of 1200mg/day or a higher dose of 1600mg/day, as follows:

The use of higher doses of PEGASYS and COPEGUS together was associated with an increase in the rate of serious adverse events compared with standard doses (up to 13 percent vs. 9 percent), an increase in the incidence of hematological abnormalities, including anemia, and an increase in premature withdrawals due to safety reasons.

"These two clinical trials underscore the commitment of Roche to finding better treatment solutions for patients living with chronic hepatitis C," said Thomas Klein, Vice President, Hepatology, Roche. "It is this commitment that has led to the status of PEGASYS as the most broadly-studied pegylated interferon, and which drives our extensive research efforts to develop new compounds and treatment strategies for hepatitis C."

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. According to the Centers for Disease Control and Prevention (CDC), an estimated 4.1 million Americans (1.6 percent) have been infected with hepatitis C; 3.2 million are chronically infected. The number of new infections per year has declined from an average of 240,000 in the 1980s to about 26,000 in 2004. CDC estimates the number of hepatitis C-related deaths could increase to 38,000 annually by the year 2010, surpassing annual HIV/AIDS deaths.

About PEGASYS

PEGASYS, in combination with COPEGUS, are indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation).

PEGASYS is dosed at 180mcg as a subcutaneous injection taken once a week. COPEGUS is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed PEGASYS with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.

Important Safety Information about PEGASYS

What is PEGASYS?

PEGASYS is a medicine used to treat some adults who have hepatitis C or hepatitis B and signs of liver damage. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.

PEGASYS (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).

What is COPEGUS?

COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the virus. Do not take COPEGUS by itself.

COPEGUS (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm your DNA and possibly cause cancer (see medication guide for more information and warnings

By Neil Osterweil, Senior Associate Editor, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco October 30, 2006

Additional AASLD Coverage

BOSTON, Oct. 30 -- Caffeine may moderate the effects of a chronic hepatitis C viral infection, but marijuana use seems to make it worse, reported French and U.S. researchers in separate studies. Action Points

Explain to patients that the studies described here suggest that marijuana can worsen liver disease in patients with hepatitis C viral infections, while caffeine may have a protective effect.

These studies were published as abstract and presented at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication. Current daily marijuana use was strongly associated with moderate to severe fibrosis in patients with chronic HCV, University of California San Francisco investigators reported at the American Association for the Study of Liver Diseases here.

"Our results indicate that HCV-infected individuals should be counseled to reduce or abstain from cannabis use," wrote Julie H. Ishida, M.D., and colleagues, in a poster presentation.

But the caffeine in three cups of coffee a day appears to have a positive protective effect on the liver, reported Christophe Hezode, M.D., of Hopital Henri Mondor, in Creteil and colleagues.

The UCSF researchers studied whether cannabis use, like heavy alcohol use, age at time of infection, and male gender could be risk factors for advanced fibrosis in patients with HCV.

They looked at 204 HCV-infected men and women who were identified by university and community-health sources. They interviewed the participants in person about demographics, risk factors for HCV, and use of marijuana and alcohol. They obtained virologic test and liver biopsy results, and scored the biopsies for fibrosis using the Ishak method (scale F0 to F6), with the scoring performed by a single pathologist blinded to clinical data.

The median patient age was 46.8 years, 69.1% of the patients were men, 49.0% were Caucasian, and 60.7% earned $15,000 a year or less. For 70.1% of the patients, the presumed route of infection was IV drug use/abuse.

The median duration of alcohol use was 29.1 years, and the patients drank an average of nearly two (1.94) drink equivalents per day.

In all, 13.7% of the participants reported using marijuana daily during the previous 12 months, while 45.1% said they used it occasionally, and 41.2% said they never used pot.

Slightly more than a fourth of patients (27.5%) had no fibrosis (F0), 55.4% had stage F1 to F2, and 27.5% had stage F3 to F6.

Moderate to heavy alcohol use, defined as two or more drinks daily for women, and four or more for men, was another independent predictor for moderate-to-severe fibrosis, with an odds ratio of 1.72 per 10 years (95% CI, 1.02-2.90, P=0.044). In addition, the presence of 11 or more portal tracts (compared with less than five) was also a strong predictor for fibrosis severity (odds ratio 6.92, 95% CI, 1.34-35.7, P=0.021).

Age at infection was of only borderline significance, the authors found, and daily use of marijuana was not strongly associated with a difference between no fibrosis and mild fibrosis, Dr. Ishida and colleagues found.

Coffee, however, was another story. Caffeine consumption may offer benefits for people with HCV, the French researchers noted.

"It has recently been suggested that caffeine consumption is associated with a lower risk of elevated serum alanine aminotransferase (ALT) activity in patients at high risk for liver disease and a lower incidence of chronic liver disease," Dr. Hezode and colleagues wrote. "This effect might be attributed to antioxidant properties of caffeine."

They conducted a study evaluating the affect of caffeine consumption on disease activity grade and ALT levels in patients with chronic HCV.

They looked at 237 consecutive treatment-na´ve patients with histologically-proven chronic HCV. They collected data on demographics, route of transmission, daily consumptions of alcohol, tobacco, and caffeine during the six months preceding liver biopsy, body mass index, HCV genotype, ALT levels at the time of liver biopsy, steatosis and activity grades, and fibrosis according to the METAVIR scoring system.

They measured caffeine intake as the sum of mean consumption of coffee, tea and caffeinated soft drinks.

The patients were 153 men and 84 women, mean age: 45.4 +11.3 years. They were classified into quartiles according to caffeine consumption.

The authors found that there was a significant inverse association between activity grade and caffeine intake (P for linear trend <0.001). They did not, however, find an association between caffeine and ALT levels.

When they performed a multivariate analysis, they found that caffeine intake greater than 407 mg a day, the amount in three cups of coffee, predicted a lowered risk of moderate-marked activity grade A2 or A3. The odds ratio for having a least a three cup a day habit was 0.473 (95% confidence interval, 0.257-0.871).